HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciDac safely and effectively. See full prescribing information for LuciDac.

INDICATIONS AND USAGE

LuciDac is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

DOSAGE AND ADMINISTRATION

Recommended Dosage: 45 mg orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 45 mg×30 tablets.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Interstitial Lung Disease (ILD): Permanently discontinue LuciDac if ILD is confirmed.

• Diarrhea: Withhold and reduce the dose of LuciDac based on the severity.

• Dermatologic Adverse Reactions: Withhold and reduce the dose of LuciDac based on the severity.

• Embryo-Fetal Toxicity: LuciDac can cause fetal harm. Advise females of reproductive potential to use effective contraception.

ADVERSE REACTIONS

Most common adverse reactions are (incidence >20%) diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

DRUG INTERACTIONS

• Proton Pump Inhibitors (PPIs): Avoid use with LuciDac; use locally-acting antacids or H2-receptor antagonist; administer LuciDac at least 6 hours before or 10 hours after H2-receptor antagonist.

• CYP2D6 Substrates: Avoid concomitant use with LuciDac where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.